The Supreme Court held claim 1 of US Patent No. 6,355,623 was representative:
A method of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder, comprising:
(a) administering a drug providing 6-thioguanine to a subject having said immune-mediated gastrointestinal disorder; and
(b) determining the level of 6-thioguanine in said subject having said immune-mediated gastrointestinal disorder, wherein the level of 6-thioguanine less than about 230 pmol per 8x108 red blood cells indicates a need to increase the amount of said drug subsequently administered to said subject and wherein the level of 6-thioguanine greater than about 400 pmol per 8x108 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.
The Court stated claim 1 tells doctors administering the drug to test for the metabolite level in the blood, and increase or decrease the dosage based on the test. The Court said these steps (e.g., administering, testing) were all conventional and added nothing to a law of nature.
Justice Breyer expressed concern that patent protection of a law of nature in this situation would inhibit further discovery by improperly tying up the future use of the law of nature. Even though patents rewarding those who discover new law of nature might encourage their discovery, the Court noted those natural laws are the basic tools of scientific and technological work.
In contrast to Myspace v. Graphon, the Supreme Court rejected the theory that sections 102, 103 and 112 could filter out unpatentable subject matter and asserted to shift the patent-eligibility requirement to Sections 102, 103 and 112 risked greater legal uncertainty.
Copyright © 2012 Robert Moll. All rights reserved.